In this position, you will be part of the development team and you will report to the Head of Development at Radboud Translation Medicine B.V. (RTM). You will work on the optimization and validation of automated processes for manufacturing of radiopharmaceutical compounds intended for use in clinical trials.

A big part of your job will be to contribute to establishing a validation strategy and writing scientific documentation required for clinical manufacturing according to GMP and ICH guidelines (e.g. procedures, validation plans, scientific reports and chemical and pharmaceutical data for Investigational Medicinal Product Dossier). Additionally, you will participate in radiolabelling experiments, in collaboration with experienced production technicians. You will contribute to method set-up and/or optimization during the development phase. You will also take part in process validation experiments, in collaboration with the production and QC team. After validation, you will remain involved in training new technicians and troubleshooting on the process.

Tasks and responsibilities

• To participate into the set-up of clinical production of radiopharmaceutical investigational medicinal products (IMPs) (from test synthesis up to a validated GMP-compliant manufacturing process).
• To contribute to the establishment of a validation strategy, following ICH standards.
• To participate in the writing and reviewing of documents (e.g. feasibility study reports, procedures, validation plans and validation reports).
• To support the Head of Development in overseeing project documentation and timelines.
• To perform radiolabelling using automated synthesis modules in a cleanroom environment during the development phase.
• To report results in a structured way both written and verbally.
• To collaborate with colleagues from RTM and external customers.
• To comply with all applicable regulations regarding radiation safety and Good Manufacturing Practices.

You are an experienced technician/scientist with excellent (English) communication skills and high affinity for writing scientific/technical documentation. You can communicate effectively with individuals from different backgrounds, internal team members and (international) external partners. You can efficiently summarize scientific content and validation strategies. Additionally, you can easily translate laboratory procedures you have witnessed into writing. You have outstanding organizational skills. You are able to work on multiple projects simultaneously and support the Head of Development on keeping oversight on deliverables and timelines.

Preferably, you already have experience with radiolabelling (e.g. with Zr-89 and/or F-18), using automated synthesis modules. Experience working in a GMP-environment and in a cleanroom is considered as an advantage.

Next to this, the following requirements apply:

• A completed study at BSc/MSc level in a relevant field (e.g. organic or analytical chemistry, radiochemistry, biochemistry).
• A minimum of 2 years of relevant working experience in a laboratory environment (industry or academia, preferably in the pharmaceutical or radiopharmaceutical field).
• A proven track record in writing scientific/technical documentation.
• Radiation safety certificate (equivalent of level 5b or higher)

Fixed-term contract: 1 year with a possible extension.

You will have an employment with Radboud Translational Medicine B.V., a 100% subsidiary of the Radboudumc. The terms of employment are in accordance with the Employee Guide RTM. In drawing up this package of employment terms and conditions, we have tried to adhere as closely as possible to the employment terms and conditions as they result from the Cao umc.

What does Radboud Translational Medicine have to offer?

• A contract of 1 year with the prospect of a permanent contract with good performance.
• A gross monthly salary between € 3.330 and € 4.429 per month (scale 8) based on full-time employment.
• An annual vacation allowance of 8% and a year-end bonus of 8.3%.
• 172 vacation hours per year based on a 36-hour work week.

Radboudumc

Radboud Translational Medicine B.V. (RTM) operates a fully equipped cyclotron facility specializing in the production of medical radioisotopes and radiopharmaceuticals, adhering to stringent European GMP guidelines. These radiopharmaceuticals support both routine clinical applications and clinical and preclinical research. For example, our products are instrumental in cancer diagnostics. We are committed to timely delivery, ensuring that hospitals in the Netherlands and internationally receive our radiopharmaceuticals as needed. Our facility houses two cyclotrons and is staffed by a dedicated team of approximately 25 professionals, producing around 800 batches annually.